Soliris Biosimilars Edge Closer In Brazil
Court’s “mailbox” patent decision opens door to competition for Alexion’s Soliris in Brazil.
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Switching patients from the very expensive ultra rare disorder drug to ravulizumab will be a key strategy for Alexion if the latter is approved. Recent compelling data in paroxysmal nocturnal hemoglobinuria patients suggests the long-acting C5 complement inhibitor could offer more benefit than its predecessor with more convenient dosing.
IMC, the R&D-based pharmaceutical industry association in Canada, says the guideline will “exacerbate an already unpredictable regulatory environment.”
Canada’s health technology appraisal body is seeking feedback on guidance on the use of real-world evidence in decision making.